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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, positioning, electric
Product CodeINO
Regulation Number 890.3110
Device Class 2

MDR Year MDR Reports MDR Events
2019 37 41
2020 41 44
2021 49 49
2022 29 33
2023 29 29
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 135 135
Electrical /Electronic Property Problem 11 15
Fire 7 7
No Audible Alarm 6 9
Use of Device Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Mechanical Problem 5 9
Material Too Rigid or Stiff 4 4
No Apparent Adverse Event 4 4
Patient Device Interaction Problem 2 2
Device Fell 2 2
Protective Measures Problem 2 2
Smoking 2 2
Break 2 2
Improper or Incorrect Procedure or Method 2 2
Sparking 2 2
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Component Missing 1 1
Positioning Problem 1 1
Unintended Collision 1 1
Unintended System Motion 1 1
Device Alarm System 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 81
No Known Impact Or Consequence To Patient 26 26
Bruise/Contusion 14 14
No Patient Involvement 12 18
Injury 11 11
Bone Fracture(s) 10 10
Burn(s) 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Laceration(s) 6 6
Pressure Sores 6 6
Pain 5 5
Abrasion 5 5
Fall 5 6
Death 3 3
Damage to Ligament(s) 2 2
Hematoma 2 2
Hemorrhage, Subarachnoid 2 2
Hip Fracture 2 2
Fracture, Arm 1 1
Numbness 1 1
Loss of consciousness 1 1
Suture Abrasion 1 1
No Information 1 1
Multiple Fractures 1 1
Muscle/Tendon Damage 1 1
Insufficient Information 1 1
Superficial (First Degree) Burn 1 1
Nerve Damage 1 1
No Consequences Or Impact To Patient 1 2
Physical Entrapment 1 1
Discomfort 1 1
Head Injury 1 1
Cardiac Arrest 1 1
Cellulitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Altimate Medical, Inc. II Nov-16-2022
2 Golden Technologies, Inc. II Aug-17-2020
3 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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